in2it (I) and (II) System A1c Test cartridges and in2it Self Test System A1c Test Cartridges, for use with the in2it (I)

FDA device recall Z-0122-2011 · posted 2010-10-22 · Terminated

Recall details

Recalling firm

Bio-Rad Laboratories Inc

Reason for recall

Inaccurate results with high bias-- Inaccurate results may be read by the machine, creating the risk for untreated hypoglycemia at elevated altitudes.

Action taken

BIO-RAD Laboratories Deeside Ltd., sent an URGENT: MEDICAL DEVICE CORRECTION letter, dated July 26, 2010, to their subsidiaries and to all customers identifying the product, the problem, and the action to be taken. Subsidiaries were to ensure that all customers received the letter with the Customer Medical Device Correction Response Form and collect the completed form from every customer. Once forms were received from all customers they were to be faxed to BIO-RAD Deeside Regulatory Affairs at +44 (0) 1244833401. Customers were instructed to run a test and visually inspect the test cartridge to detect any residual clear liquid. If the cartridge did not run properly the test was to be rejected. Customers were to run Quality Control test with each new shipment of test cartridges. Patient's results were not to be reported if the QC failed. Customers were to complete the CUSTOMER MEDICAL DEVICE CORRECTION RESPONSE FORM and fax it to the number provided on the form. For questions customers were to contact their regional BIO-RAD office.

Root cause

Device Design

Status

Terminated

Product code

LCP

Quantity affected

90703

Distribution

Product was distributed to Bio-Rad's US subsidiary, along with 18 other distribution subsidiaries outside the US. These distributed further to other consignees. POroduct was distributed to Mexico, Kor

Date initiated

2010-07-26

Date posted

2010-10-22

Date terminated

2011-10-25

Location

Hercules, CA

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